Transspinal Stimulation Plus Locomotor Training for SCI

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    45
  • sponsor
    City University of New York
Updated on 19 June 2022
electrical stimulation
spinal cord
gait training
spinal cord disorder
locomotor training

Summary

Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury. Excitingly, the benefits of locomotor training may be augmented by noninvasive electrical stimulation of the spinal cord and enhance motor recovery at SCI. This study will compare the effects of priming locomotor training with high-frequency noninvasive thoracolumbar spinal stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of brain and spinal cord function will be performed before and after 40 sessions of locomotor training where spinal stimulation is delivered immediately before either lying down or during standing.

Description

Spinal cord injury (SCI) greatly impairs standing and walking ability, which severely compromises daily living activities. While these deficits are partially improved by locomotor training, even after multiple training sessions, abnormal muscle activity and coordination still persist. Thus, locomotor training alone cannot fully optimize the neuronal plasticity required to strengthen the synapses connecting the brain, spinal cord, and local circuits. As such, treatment interventions that effectively promote neuromodulation of spinal locomotor networks and strengthen neural connectivity of the injured human spinal cord in combination with physical rehabilitation are greatly needed. It is proposed that transcutaneous spinal cord (transspinal) stimulation as a method to synergistically 'prime' the nervous system to better respond to locomotor training. Transspinal stimulation alters motoneuron excitability over multiple spinal segments, a pre-requisite for functioning descending and local inputs. Importantly, whether concurrent treatment with transspinal stimulation and locomotor training maximizes motor recovery after SCI is unknown. The goal of this clinical trial is to use high frequency (30 Hz) transspinal stimulation to prime locomotor training and ultimately improve standing, walking, and overall function in individuals with chronic incomplete SCI (iSCI). Forty-five individuals with iSCI will undergo 40 sessions of body weight-supported step training primed with high-frequency transspinal stimulation. Participants will be randomized to receive transspinal stimulation during standing (real or sham) or while supine (real). Aim 1 evaluates how priming locomotor training with high-frequency transspinal stimulation in SCI alters corticomotoneuronal connectivity strength, as indicated by motor evoked potentials recorded from the legs.

Aim 2 evaluates how priming locomotor training with high-frequency transspinal stimulation in iSCI affects reorganization and appropriate engagement of spinal neuronal circuits. Finally, Aim 3 evaluates activity-based motor function, ability to stand and walk, and quality of life. These results will support the notion that tonic high-frequency transspinal stimulation strengthens corticomotoneuronal connectivity and improves spinal circuit organization through posture-dependent corticospinal neuroplasticity. It is anticipated that the information gained from this mechanistic clinical trial will greatly impact clinical practice. This is because in real-world clinical settings, noninvasive transspinal stimulation can be more easily and widely implemented than invasive epidural stimulation.

Details
Condition Spinal Cord Injuries, Paraplegia, Spinal, Tetraplegia/Tetraparesis, Paraplegia, Spastic
Treatment Standing transspinal stimulation followed by robotic gait training, Lying transspinal stimulation followed by robotic gait training, Standing sham transspinal stimulation followed by robotic gait training
Clinical Study IdentifierNCT04807764
SponsorCity University of New York
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willingness to comply with all study procedures and availability for the duration of the study
Ability to understand the consent form, and sign the consent form
Male or female, age 18-70 years old
In good general health as evidenced by medical history
Diagnosed with motor incomplete SCI (AIS C-D)
Bone mineral density of the hip (proximal femur) T-score <3.5 SD from age- and gender-matched normative data
Lesion above thoracic (T) 10 to ensure absent lower motoneuron lesion
Presence of tendon reflexes to be able to elicit the soleus H-reflex
Absent permanent ankle joint contractures that prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat require also flexible ankle joints
A diagnosis of first time SCI due to trauma, vascular, or orthopedic pathology
Time after SCI of more than 6 months
Stable medical condition without cardiopulmonary disease or cognitive impairment

Exclusion Criteria

Supraspinal lesions
Significant neuropathies of the peripheral nervous system
Significant degenerative neurological disorders of the spine or spinal cord
AIS A or B
Presence of pressure sores
Advanced urinary tract infection
Neoplastic or vascular disorders of the spine or spinal cord
Participation in an ongoing research study or new rehabilitation program
Pregnant women or women who suspect they may be, or may become pregnant will be excluded from participation because the risks of thoracolumbar stimulation to the fetus are unknown
People with cochlear implants, pacemaker, implanted infusion device, and/or implanted stimulators of any type and purpose will be excluded to avoid their malfunction due to stimulation
People with history of seizures
Medical conditions that increase the possibility of seizures
Medications that may change the seizure threshold
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